Federal investment in Biodefense is up 17 times, and the President has proposed another
significant increase for next year.

Combined HHS and DHS Biodefense preparedness spending:

FY 2001 -- $294 million [HHS budget]

FY 2002 -- $3 billion [HHS budget]

FY 2003 -- $4.4 billion [combined HHS and DHS
budgets for Biodefense]

FY 2004 -- $5.2 billion [combined HHS/DHS -
incl. BioShield proposal]

An unprecedented partnership effort with
states and hospitals was launched quickly.

A total of $2.7 billion has
been made available for state, local and hospital preparedness since
2001. Another $1.5 billion is being provided this year, with a further
$1.3 billion proposed for FY 2005.

These awards comprise two programs:
CDC's program to upgrade state and local capacity ($2 billion to date);
and HRSA's program for hospital preparedness ($650 million to date).

Funds go through state public health agencies, but 75 percent will
ultimately go for direct or indirect support of local public health
departments and hospitals.

States are drawing these funds as quickly
as they are able to ramp up their preparedness efforts and invest the
money productively.

Public health systems are already much stronger
and better prepared for bioterrorism and other mass casualty
incidents.

All 50 states have bioterrorism response plans in place,
including mass vaccination plans (few states had such planning in
2001.)

All states have established systems to rapidly detect a
terrorist event through mandatory reportable disease detection
systems.

90 percent of CDC awardees so far report they could initiate
a field investigation within six hours of receiving an urgent disease
report.

Alll States have plans in place for receiving and distributing Push Packages from the Strategic National Stockpile.

States are
updating their laws for dealing with public health emergencies, using
the draft model legislation on emergency health powers that was
prepared by CDC. As of 2003, 32 states and the District of Columbia had
passed bills or resolutions related to the draft model legislation.

More workers and expertise have been directed at public health
emergency preparedness.

Within the past 18 months, at least 3,850 new
state and local public health staff have been funded (in whole or part)
by the CDC awards.

HHS staff dedicated to public health emergency
preparedness in now 1,700, up from 212 in FY 2001. Next year, the
number will rise again, to over 2,000.

CDC has trained 500 staff for
immediate emergency support. CDC is also providing expert staff to
state and local public health agencies, with 500 to be assigned out by
2008.

CDC continues to provide expert assistance, especially through
its "disease detectives," the Epidemic Intelligence Service. This
two-year program has grown from 148 EIS officers in 2001 to 168 in
2004.

America's public health laboratory capacity, a crucial element
in detecting and understanding any disease outbreak, is greatly
expanding.

The Laboratory Response Network, connecting labs of many
kinds that can help in an emergency, has been expanded to 120 member
labs in all 50 states, up from 80 labs in 2001. By the end of FY 2004,
the network will include 145 member labs. This includes 47 state and
local public health labs at the BSL-3 biosecurity level, four times the
number in 1999.

Eleven new
high-level biocontainment research laboratories are being funded by NIH
primarily for research purposes, but they would also be available to
assist in public health response to bioterrorism or infectious disease
emergencies.

Communications capacity within the public health
structure has been expanded and improved.

CDC's Public Health
Information Network can reach 1 million recipients quickly, including
90 percent of all county public health agencies so far, up from 68
percent in 2001.

CDC's EPI-X system also connects more than 1,800
public health officials for immediate sharing of emergent public health
data, compared with 200 in 2001.

These improvements will help make
public communications clearer and faster in an emergency.

Hospital
preparedness efforts have resulted in new state- and region-wide
coordination, with coherent plans for investment and response.

For the
first time, a nationwide initiative bought about joint planning for
public health emergencies by public systems and hospitals working
together toward federally-identified goals.

All states have developed
plans with their hospitals for dealing with mass casualty incidents,
including terrorism, accidents or naturally-occurring disease.

Nationwide training for health care professionals is being implemented,
and scientific expertise is growing.

Almost 174,000 health
professionals are being trained in FY 2003 and 2004 through HRSA's
Bioterrorism Training and Curriculum Development program, with 19
grants for continuing education aimed at the diverse health care
workforce, and 13 grants to health professions schools to develop
curricula.

NIH's new "Regional Centers of Excellence for Biodefense
and Emerging Infectious Diseases" will build a strong infrastructure
for research and development while also developing our base of
scientific expertise by training a new generation of science
professionals to perform Biodefense research.

CDC's Centers for Public
Health Preparedness (CPHP) help prepare frontline health workers at the
local level. There are now 34 CPHPs in 46 states, comprised of schools
of public health, schools of medicine and other local institutions.

Federal emergency resources have been expanded to back-up local
resources when they become overwhelmed.

The Strategic National
Stockpile has increased 50 percent since 2001, now including twelve
50-ton "Push Packages," up from eight. The amount and variety of
stockpile contents has also grown.

The National Disaster Medical
System has 33 percent more personnel for its emergency response teams -
8,000 personnel today, up from 6,000 in 2001.

HHS had quadrupled the
Readiness Force in the U.S. Public Health Service Commissioned Corps,
from 600 in 2001 to almost 2,300 today.

FDA is implementing the most
fundamental enhancements of its food safety activities in many years.

FDA has more than doubled its presence at ports of entry, from 40 ports
in 2001 to 90 ports today.

This year, FDA is performing 60,000
inspections of imported foods, five times more than in 2001. In FY
2005, FDA proposes to conduct 97,000 inspections, eight times higher
than 2001.

FDA is implementing its new authority for registration of
food facilities (some 425,000 are expected to register); for prior
notification of food import shipment (some 20,000 notices per day
expected); and for record-keeping and administrative detention of
suspected foods.

FDA has created a Food Emergency Response Network,
with 63 labs representing 34 states - no such network existed in 2001.

FDA is expanding its eLEXNET communications network for immediate
exchange of critical food testing data. At present, there are 108
laboratories representing 49 states and the District of Columbia. They
are capable of dealing with more than 3,700 analytes. In 2000, there
were eight labs, capable of tracking a sole analyte.

The Biodefense
research initiative is the largest single increase in resources for any
initiative in the history of NIH.

Biodefense research funding at NIH
has increased from $53 million in FY 2001 to $1.6 billion in FY 2004.

The increased effort is guided by strategic plans developed with the
guidance of panels of scientific experts.

More than 50 biodefense
initiatives have been developed to address research and development
priorities in therapeutics, vaccines, diagnostics, and basic research
including genomics, proteomics and bioinformatics.

NIH has invested
more than $800 million for 11 extramural labs and three intramural
labs, and physical security. These are critical to developing
countermeasures against agents of bioterror.

NIH will emphasize
product development and cooperative enterprises with private industry
and academia, in addition to its traditional role of supporting basic
scientific research.

Progress in Biodefense research has been swift
and substantial.

New and improved vaccines against smallpox, anthrax,
and other potential bioterror agents are being developed and evaluated
and will soon enter the national stockpile through Project BioShield.

NIH rapidly developed a fast-acting Ebola virus vaccine and showed its
efficacy in monkeys; it is now being tested in human volunteers.

NIH-supported scientists have identified antivirals that may play a
role in treating smallpox or the complications of smallpox vaccination,
as well as new antibiotics and antitoxins against other major bioterror
threats.

NIH has established eight Regional Centers of Excellence for
Biodefense and Emerging Infectious Diseases Research (RCE). This
nationwide group of multidisciplinary centers is a key element in the
HHS strategic plan for biodefense research.

NIH has supported the
genomic sequencing of all bacteria (including the anthrax bacterium)
considered to be bioterror threats, as well as the sequencing of
genomes for at least one strain of every potential viral and protozoan
bioterror pathogen.

Capacity is being expanded to produce medical
countermeasures to protect Americans from bioterrorism attacks.

The
supply of smallpox vaccine has increased from 15.4 million doses
available in 2001, to more than 300 million full doses today, enough to
vaccinate every American, if necessary.

The Strategic National
Stockpile includes enough antibiotic to treat 20 million people for
anthrax exposure, significantly higher than in 2001. Research is also
underway toward an improved anthrax vaccine.

The President has
launched the BioShield initiative, to create a more stable and assured
source of funding to purchase new vaccines or treatments. BioShield
will provide $5.6 billion over the next 10 years for new products.

FDA
has approved new medical countermeasures, including therapies for
anthrax, radiation exposure and antidotes to nerve agent poisoning. FDA
has also implemented programs to facilitate development of new
products.

In the past two years, FDA finalized the "animal rule," which
provides for using animals to test the safety and efficacy of products
where human tests would be unfeasible. This rule can important in
development of many Biodefense countermeasures.

Federal coordination
and capacity has been expanded.

The Department of Homeland Security
creates a focal point for federal leadership.

HHS has created a
top-level Office of Public Health Emergency Preparedness to coordinate
Department-wide efforts.

HHS operating divisions work closely with
states, providing specific performance measures and benchmarks, with
semi-annual review of progress. HHS' Office of Inspector General is
also increasing its activities to ensure proper accounting and
expenditure of federal support.

In collaboration with the Department
of Justice, CDC launched the "Forensic Epidemiology" course in 2002 to
train frontline public health, public safety and law enforcement
professionals to conduct effective joint investigations. So far, 42
states have elected to take part, and 5,000 professionals have been
trained.